1-Ethyl-4-nitroso-piperazine;65504-33-8
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：N031268
English Name：1-Ethyl-4-nitroso-piperazine
English Alias：1-ethyl-4-nitrosopiperazine
CAS No.：65504-33-8
Molecular Formula：C₆H₁₃N₃O
Molecular Weight：143.19
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for nitroso-piperazine impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common solvents like methanol and acetonitrile within 6 months.
Quality Control Testing：Used for nitroso impurity detection in APIs and formulations of piperazine-containing drugs (such as antidepressants and antipsychotics), controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during piperazine drug synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and pH.
Method Validation：Serves as a standard for developing nitroso-piperazine impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
1-Ethyl-4-nitroso-piperazine belongs to nitrosoamine compounds, which have potential genotoxicity and carcinogenicity. During the synthesis of piperazine-containing drugs, this impurity may originate from nitrosation side reactions of the piperazine ring or result from the reaction between nitrites in raw materials and piperazine compounds under acidic conditions. Due to the potential safety risks of nitroso compounds, global regulatory agencies have extremely strict control requirements, making the study of this impurity crucial for ensuring related drug quality.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3 minutes, with LOD of 0.002 ng/mL for high-precision trace nitroso impurity analysis.
Formation Mechanism：Formed by electrophilic substitution of piperazine with sodium nitrite under acidic conditions (e.g., acetic acid or hydrochloric acid systems); optimizing reaction pH and reducing nitrite residues inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 168.3 μM against A549 cells, with potential DNA damage capacity. Long-term stability testing is ongoing to systematically monitor degradation characteristics under different storage conditions, providing data for optimizing drug storage conditions.
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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